An interventional study of Telerehabilitation and Conventional home exercise program in Rotator Cuff Tear, Telemedecine and Rotator Cuff Injuries, sponsored by Hanoi Medical University. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Hanoi Medical University · Not applicable, Interventional, and Treatment
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.
Shoulder pain is the third most common medical condition seen in primary care settings, with 65-70% of patients experiencing rotator cuff injuries. Therefore, rotator cuff injuries significantly impact patients' mobility and place a considerable burden on the healthcare system and employers. The majority of patients are treated conservatively; however, approximately 40% of patients with rotator cuff tears, in which the primary injury is a tear of the supraspinatus and infraspinatus tendons, experience persistent pain and require surgical intervention. Effective rehabilitation programs can address disability and functional impairments in patients, such as joint range of motion, muscle strength, and persistent pain.
However, not all patients who have undergone rotator cuff surgery have full access to in-person rehabilitation programs due to geographical, financial, and awareness barriers, or other objective factors such as epidemics. Furthermore, many patients lack the skills and knowledge to perform guided exercises at home, or receive inadequate guidance. In this context, tele-rehabilitation is considered a potential solution to mitigate the drawbacks of in-person and self-training methods.
This study was designed to address gaps in practical implementation by evaluating whether the addition of a culturally adapted smartphone-based telerehabilitation application to standard postoperative physiotherapy could improve clinical outcomes compared to using standard physiotherapy alone.
The primary objective was to determine the effectiveness of combined telerehabilitation intervention on shoulder function, as measured by changes in Constant-Murley and Quick DASH scores 24 weeks after arthroscopic repair of rotator cuff tendon injuries.
Secondary objectives include assessing the impact of the intervention on active range of motion, isotonic shoulder strength, pain intensity, specific functional capacity of the patient, psychological factors (movement anxiety and rehabilitation confidence), treatment adherence, health-related quality of life, return to work status, direct non-medical costs, and caregiver time burden. The study will also assess safety through the rate of rotator cuff re-tear after 24 weeks and investigate factors related to treatment response. The study employs a comprehensive biopsychosocial assessment. Beyond physical recovery, we evaluate the interplay between psychological barriers (kinesiophobia via TSK-11), psychological assets (self-efficacy via SER), and resulting clinical behavior (adherence via EARS) to provide a holistic view of the patient's rehabilitation journey.
This is a randomized, controlled, single-center clinical trial conducted at Viet Duc Friendship Hospital in Hanoi, Vietnam. A total of 102 patients eligible for arthroscopic rotator cuff repair are expected to be recruited and randomized in a 1:1 ratio into either the intervention or control group using a computer-generated block randomization. During the first 6 weeks post-surgery, all patients received direct instruction in physical therapy with a total of 6-8 treatment sessions. After 6 weeks, patients were divided into two groups.
Participants in the intervention group received the hospital's standard surgical physiotherapy protocol along with access to a dedicated smartphone application. This application provided daily exercise instruction videos tailored to each rehabilitation phase, automatic reminders, real-time compliance monitoring, and asynchronous communication with the physiotherapist for remote feedback and progress tracking.
Participants in the control group received only the hospital's standard surgical physiotherapy protocol and were explicitly instructed not to use any additional rehabilitation applications or online exercise programs throughout the 24-week study period.
All participants followed the same standard three-phase rehabilitation protocol developed by the hospital's Department of Rehabilitation based on the Vietnamese Ministry of Health guidelines and Massachusetts General Hospital:
Phase 1 (weeks 0-6): Assisted passive protection and movement. Phase 2 (weeks 6-12): Active movement, starting with light resistance. Phase 3 (weeks 12-24): Gradual strengthening and rehabilitation. Assessment of outcomes was planned at baseline (pre-surgery), 6 weeks, 12 weeks, and 24 weeks post-surgery. The primary endpoint was the change in Constant-Murley and Quick DASH scores from baseline to 24 weeks. Secondary criteria include active range of motion measured by an angle measuring device, isotonic shoulder strength measured by a handheld dynamometer (forward flexion, abduction, external rotation, and internal rotation), visual analog scale (VAS) for pain at rest and during activity, Patient-Specific Functional Scale (PSFS), Tampa Scale of Movement Aversion (TSK-11), Self-Effect Scale of Rehabilitation (SER), Exercise Compliance Scale (EARS), EQ-5D-5L for quality of life, time and extent of return to work, total direct non-medical costs, and number of lost workdays for caregivers. Rotator cuff tendon integrity will be assessed after 24 weeks using ultrasound or MRI.
Data will be collected using a standard electronic case report form. When participants are unable to attend in-person consultations, data collection will be conducted through structured telephone interviews or home visits by trained research staff, with the methodology clearly documented for each assessment to allow for sensitivity analysis.
The study will be conducted in full compliance with the Helsinki Declaration and the ICH Good Clinical Practice guidelines. This study has been approved by the Medical Ethics Committee of Hanoi Medical University. All participants will provide written informed consent before enrollment.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
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Diagnosis: Confirmed symptomatic rotator cuff tear requiring surgical intervention, specifically involving:
Cognitive and Functional Capacity:
Documentation and Consent:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will perform a structured home-based rehabilitation program guided by a mobile application (RehaX, RealPT). The app provides instructional videos for exercises, daily reminders, and a digital diary to track progress. Additionally, patients can communicate with physiotherapists through a built-in messaging system for guidance and adjustments to their exercise protocol. For the first six weeks, patients receive direct instruction from a physiotherapists. After six weeks, patients receive instruction guided by the mobile application.
Procedure: Telerehabilitation
Patients in this group will follow a standard home rehabilitation program. They will receive a printed booklet with still images and written instructions on the same exercise regimen as the experimental group. For the first six weeks, patients will receive direct instruction from a rehabilitation technician. After six weeks, patients will exercise independently at home. No digital monitoring devices or mobile applications will be provided; patients will monitor their health status with therapists during regular clinic visits.
Procedure: Conventional home exercise program
High-quality instructional videos on each stage of the personalized exercise program, with AI-assisted observation and correction for post-surgical rotator cuff tendon repair. Daily automated reminders to keep patients informed of their exercise schedule. Interactive digital log to record completed sessions and pain levels. Asynchronous communication with a physical therapist for guidance and program adjustments. The program is designed to enhance treatment adherence and track patient progress in real time throughout the 6-month rehabilitation period.
Also known as: App-based home exercise program, Mobile Health rehabilitation
The control intervention consists of a conventional home-based exercise program. Patients will receive: During the first 6 weeks, patients will be trained directly by a physical therapist. A printed brochure containing static illustrations and written step-by-step instructions for the post-operative rotator cuff rehabilitation protocol. Standard verbal education from a physiotherapist during the directly training session. Having digital mobile reminders one time per week; patients are expected to manage their exercise frequency independently. Communication with the medical team is limited to scheduled follow-up visits at the hospital and when called by mobile. This group serves as the active comparator to evaluate the added value of the digital mobile application intervention.
Change in Constant-Murley score from baseline to 24 weeks post-surgery
The Constant-Murley Shoulder Score is a validated shoulder-specific outcome measure that evaluates pain, activities of daily living, range of motion, and strength (total score 0-100, higher scores indicate better function). The primary outcome is the mean change in Constant-Murley score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
Time frame: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
Change in Quick DASH score from baseline to 24 weeks after arthroscopic rotator cuff repair
The Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) is a patient-reported questionnaire assessing upper extremity physical function and symptoms (score 0-100, lower scores indicate better function). The primary outcome is the mean change in Quick DASH score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
Time frame: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
Change in active range of motion of the operated shoulder from baseline to 24 weeks
Active range of motion (forward flexion, abduction, external rotation, and internal rotation) measured with a goniometer. Change from pre-operative baseline to 24 weeks will be compared between groups.
Time frame: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively
Change in isometric shoulder strength from baseline to 24 weeks
Isometric muscle strength of the operated shoulder (forward flexion, abduction, external rotation, and internal rotation) measured with a handheld dynamometer (kg). The mean of three trials is recorded. Change from baseline to 24 weeks will be compared between groups.
Time frame: Assessed at baseline (pre-operative), 12 weeks, and 24 weeks post-operatively
Change in pain intensity (VAS) at rest and during activity from baseline to 24 weeks
Pain intensity measured using the Visual Analog Scale (VAS 0-10) at rest and during activity. Change from pre-operative baseline to 24 weeks will be compared between the intervention and control groups.
Time frame: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively
Change in Tampa Scale for kinesiophobia (TSK-11) from baseline to 24 weeks
The TSK-11 is a patient-reported questionnaire used to assess fear of movement or injury. It consists of 11 items, each scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 11 to 44. A higher total score indicates a higher degree of kinesiophobia (greater fear of movement).
Time frame: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively.
Rotator cuff re-tear rate at 24 weeks post-operatively
Incidence of rotator cuff re-tear confirmed by ultrasound or MRI at 24 weeks after surgery. The proportion of re-tear will be compared between the tele-rehabilitation group and the control group.
Time frame: At 24 weeks after arthroscopic rotator cuff repair
Time and level of return to work at 24 weeks
Time (weeks) to return to work and level of return to work (not returned / part-time / full-time same job / full-time heavier duty). These will be compared between groups.
Time frame: Assessed at 12 weeks and 24 weeks post-operatively
Change in Health-related quality of life (EQ-5D-5L) at 24 weeks
Health-related quality of life is assessed using the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire. It consists of two parts: the EQ-5D descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from 1 (no problems) to 5 (extreme problems/unable to). These levels are converted into a single index score (typically ranging from 0 to 1, where 1 indicates perfect health). The EQ VAS records the patient's self-rated health on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine)
Time frame: Assessed at 24 weeks post-operatively
Change in Self-Efficacy for Rehabilitation Scale (SER) at 24 weeks
The SER scale assesses a patient's belief in their ability to perform rehabilitation tasks. It consists of 12 items, each scored from 0 (not confident at all) to 10 (completely confident). The total score ranges from 0 to 120. Higher scores indicate higher self-efficacy and greater confidence in the patient's ability to successfully engage in the rehabilitation process
Time frame: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively
Change from baseline in Exercise Adherence Rating Scale (EARS) at 24 weeks.
The EARS measures the level of adherence to prescribed home exercise programs. It consists of 6 items focusing on adherence behavior. Each item is scored on a 4-point Likert scale from 0 (strongly disagree) to 3 (strongly agree). The total score for this section ranges from 0 to 18. Higher scores represent better adherence to the exercise protocol.
Time frame: 6 weeks, 12 weeks, 24 weeks post-operatively
Total Direct Non-Medical Costs at 24 weeks.
This measure assesses the economic burden of the treatment process. It includes the total accumulated expenses for transportation, meals, and lodging incurred by the patient and their family during hospital visits and rehabilitation sessions over the 24-week period. Data are collected via a structured cost questionnaire. Results are expressed as the total amount in Vietnam Dong (VND)
Time frame: 24 weeks (accumulated from baseline)
Caregiver Productivity Loss at 24 weeks
Caregiver burden is measured by the total number of work-days lost by the primary caregiver due to assisting the patient with hospital visits, rehabilitation sessions, or home care activities related to the recovery process. This is recorded as a cumulative number of days over the 24-week study period
Time frame: 24 weeks (accumulated from baseline)
Plan to share: No
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Hanoi Medical University